Data / Medical devices / Israel / Bioview Ltd.
Bioview Ltd.: FDA-registered device maker in REHOVOT Central, Israel, 1 510(k) clearance
Bioview Ltd. is registered with the FDA (registration 3003909093) in REHOVOT Central, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003909093
- Address
- 3 Pakris Street, REHOVOT Central, Israel, 76702
- Owner or operator
- BIOVIEW LTD. (9054795)
- Roles
- Manufacturer
- First device listed
- May 5, 2003
- Registered through
- 2026
- Brand names listed
- Accord Plus, Allegro Plus, BIOBLUE, BIOBLUE AMNIO, BIOBLUE DROP, BIOWHITE, BIOWHITE-AMNIO, BIOWHITE-SUPPLEMENT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Automated Cell-Locating | JOY | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | NTH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2014 | K130775 | DUET SYSTEM | NTH | Substantially Equivalent | Bioview , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- All makers of Device, Automated Cell-Locating
- All makers of General Purpose Reagent
Updated May 9, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.